FIG. 23:  To test the hypothesis that treating patients with heart failure and either OSA or CSA with ASV would improve outcomes, we initiated the Adaptive Servo Ventilation for treatment of OSA and CSA in Heart Failure (ADVENT-HF ) trial, jointly funded by the Canadian Institutes of Health Research (CIHR) and an unrestricted grant from Philips Respironics.^[12]  As shown in this Figure, the inclusion criteria are patients with systolic heart failure aged >18 years with LVEF ≤45%, on optimal heart failure therapy, who then undergo a sleep study.  If the AHI is ≥15, they are eligible for enrollment and subdivided into those with predominant OSA or predominant CSA, with a stratified analysis of those two groups separately planned for the end of the trial.

The patients undergo a baseline assessment of quality of life; brain natriuretic peptide (NT-pro-BNP); 6-min walk test; and LVEF, LV end-diastolic volume, and LV mass by echocardiography.  They are then randomized to a control group that does not receive ASV or to an ASV-treated group that receives ASV titration in a sleep lab to eliminate OSA or CSA.  We calculate the sample size for this trial at about 860.  This is an event- driven trial that will end once 540 primary events have occurred.  The primary outcome is a composite of death, first cardiovascular hospitalization, appropriate ICD shock not requiring hospitalization, and atrial fibrillation/flutter requiring anticoagulation but not requiring hospitalization over the follow-up period.